22.214.171.124.1 Low- and High-Risk Drugs
The pharmacological activities of drugs have a significant impact on the cleaning validation program. Materials of lower pharmacological activity do not have major issues in setting residual limits for cleaning validation. However, there are numerous materials and formulations where even minute quantities can have pharmacological activity. In such cases, although the equipment and cleaning procedures might be the same, tighter limits will be required for products with known adverse effects. Besides this, sampling and analytical methods also need to be refined to a high degree of sensitivity to ensure the removal of residue from equipment.
The approach for cleaning equipment utilized for different dosage forms is significantly different. The difference is related to how contamination can be left on equipment and mixed with subsequent products. This can be understood by taking the following example: liquid product has a greater ability to penetrate equipment seals and joints, whereas solid product can form tufts or clumps on the surface, which may prevent wetting of that part by cleansing agents and thus inhibit the ability to rinse the residues properly. The same phenomenon can be true for the dispersion of contaminant on the surface of the equipment for solid and liquid products. The distribution of contaminants in the case of solid products may vary from point to point while that in liquid products is uniform across the surfaces.
The removal of insoluble materials from the equipment surface represents yet another difficult scenario because it requires more physical means as compared to soluble materials (active or excipient), which are often easily removed by solubilizing the product. The removal of insoluble or less soluble materials by adding cleaning agents results in increased wetting and solvation of the materials.
Sterile manufacturing facilities differ from nonsterile ones because of the extra precautions required to control microbial and endotoxin levels. In nonsterile products, environmental concerns are reduced but are still important. This is because objectionable microorganisms are also common in oral liquids and topical, similar practices are required to minimize these organisms here.
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